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MELA Sciences, Inc. Message Board

  • equityvaluation equityvaluation Feb 17, 2011 9:54 PM Flag

    FDA's lap-band decision may have implications for MELA

    Although Allegan had won approval from the FDA'S Advisory committee (just like MELA) there was a lot of concern and opposition that made people wonder if the FDA would approve the expanded use. The important question was whether all of this is good for weight-loss patients. More to the point: was any of it good for the patients? Allergan is an aggressive marketer of the Lap-Band to consumers, many of whom don't have a clue when it comes to assessing the dangers of what is, after all, major surgery. Here's what happened today: Excerped from the LA Times:

    The Food and Drug Administration on Wednesday cleared the way for marketing the procedure to patients who are significantly less obese than those who qualify now — a decision that would make an estimated 26.4 million more Americans eligible to consider the Irvine company's device. The approval also means that, according to company officials, 45.6 million Americans meet the criteria for Lap-Band surgery. That's more than 1 in 7.

    The Lap-Band is an inflatable ring that is surgically implanted around the upper portion of the stomach. Once the surgical wounds have healed, saline solution is injected into the ring to expand it, limiting the amount of food that can be consumed during a meal.

    Over the last two years, four Southern California patients have died shortly after undergoing Lap-Band weight-loss surgery at two clinics connected to a television, radio and billboard marketing campaign touting the toll-free number 1-800-GET-THIN, according to lawsuits, family interviews and coroners reports.

    Kushner noted that the FDA was willing to accept the inherent hazards of surgery but recently rejected three diet drugs — Lorcaserin, Qnexa and Contrave — because it judged that the drugs' risks outweighed benefits.

    http://www.latimes.com/business/la-fi-allergan-lap-band-20110217,0,2296064.story

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